I4 (Integrated Intelligent Imaging Informatics) system

K160315 · Philips Medical Systems Nederland B.V. · LLZ · Feb 19, 2016 · Radiology

Device Facts

• Record ID: K160315
• Device Name: I4 (Integrated Intelligent Imaging Informatics) system
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: LLZ · Radiology
• Decision Date: Feb 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists. I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage. This device is not to be used for mammography.

Device Story

I4 is a software-based image management system (PACS) operating on general-purpose computing hardware; used by radiologists and trained professionals in clinical environments. It acquires, stores, distributes, processes, and displays medical images and non-imaging data. Input data includes DICOM studies from various modalities (CT, MR, US, XA, DX, CR, RF, PT, SC) and hospital/radiology information system data. The system provides 2D/3D visualization, multi-planar reconstruction (MPR), volumetric rendering (MIP, MinIP, VIP, surface MIP, average), and advanced vessel analysis. It includes measurement and annotation tools for 2D/3D modes and segmentation tools (e.g., bone/skull removal). Output is displayed on high-resolution diagnostic monitors to assist clinicians in image evaluation and interpretation. The system integrates non-imaging data in patient context (Mission Briefing). It functions as a client-server architecture, supporting multiple concurrent users and interoperability with hospital systems via HL7 and DICOM. The device aids clinical decision-making by providing advanced visualization and quantification tools for diagnostic review.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including verification and validation of software requirements, risk management, and compliance with consensus standards (ISO 14971, IEC 62304, IEC 62366-1, NEMA-PS 3.1-3.20).

Technological Characteristics

Software-based PACS running on general-purpose computing hardware with Windows OS. Uses client-server architecture and TCP/IP networking. Supports high-resolution diagnostic monitors and multiple concurrent users. Implements DICOM and HL7 interoperability. Features include 2D/3D image processing, volumetric rendering, MPR, and segmentation tools. Software life cycle follows IEC 62304.

Indications for Use

Indicated for trained professionals, including radiologists, for the acquisition, storage, distribution, processing, and display of medical images and associated data in a clinical environment. Not indicated for mammography.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• IntelliSpace PACS 4.x (K111804)

Reference Devices

• ViewForum 2003 (K032096)
• Brilliance iCT (Brilliance Volume) (K060937)
• VesselNavigator (K151598)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2016

Philips Medical Systems Nederland BV % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K160315

Trade/Device Name: 14 (integrated Intelligent Imaging Informatics) System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, JAK Dated: February 3, 2016 Received: February 5, 2016

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160315

#### Device Name

I4 (Integrated Intelligent Imaging Informatics) system

Indications for Use (Describe)

I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists.

I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.

This device is not to be used for mammography.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# 14 (Integrated Intelligent Imaging Informatics)

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92.

Date Prepared: December 15, 2015

### I. Submitter's name and address

| Manufacturer: | Philips Medical Systems Nederland B.V.<br>Veenpluis 4-6<br>5684 PC Best<br>The Netherlands<br>Establishment Registration Number: 3003768277 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ilana Ben Moshe<br>Regulatory Affairs Expert<br>Phone: [phone]<br>E-mail: [e-mail] |

### II. Device information

#### Subject Device:

Device Name:

I4 (Integrated Intelligent Imaging Informatics) system Common/Usual Name: Imaging Informatics System Classification: Classification name: Picture Archiving and Communications System Device class: Class II Classification regulation: 21 CFR 892.2050 Classification panel: Radiology Primary Product Code: LLZ Secondary Product Code: JAK

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#### III. Predicate device information

#### Primary Predicate Device:

| Trade name: | IntelliSpace PACS 4.x |
|----------------------------|---------------------------------------------|
| Manufacturer: | Philips Healthcare Informatics, Inc. |
| 510(k) clearance: | K111804 |
| Classification name: | Picture Archiving and Communications System |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2050 |
| Classification panel: | Radiology |
| Product code: | LLZ |

#### Reference Predicate Devices:

| Trade name: | ViewForum 2003 |
|----------------------------|-----------------------------------------------|
| Manufacturer: | Philips Medical Systems North America Company |
| 510(k) clearance: | K032096 |
| Classification name | System, Image Processing |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2050 |
| Classification panel: | Radiology |
| Product code: | LLZ |

Brilliance iCT (Brilliance Volume) Philips Medical Systems(Cleveland), Inc. K060937 System, X-Ray, Tomography, Computed Class II 21 CFR 892.1750 Radiology JAK

### Reference Device:

Trade name:

Manufacturer:

Device class:

Product code:

510(k) clearance:

Classification name:

Classification panel:

Classification regulation:

| Trade name: | VesselNavigator |
|----------------------------|---------------------------------------------|
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| 510(k) clearance: | K151598 |
| Classification name | Image-intensified fluoroscopic x-ray system |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.1650 |
| Classification panel: | Radiology |
| Product code: | OWB, LLZ |

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#### IV. Device Description

I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists.

I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.

This device is not to be used for mammography.

I4 (Integrated Intelligent Imaging Informatics) is a medical software system offering a primary interpretation solution for visualization and evaluation a variety of medical images deriving from various imaging modalities as well as non-imaging information. I4 interconnects with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.

## V. Indications for Use

I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists.

I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.

This device is not to be used for mammography.

### Indications for Use Discussion

The proposed device I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment, identical to the primary predicate device, IntelliSpace PACS 4.x (K111804).

I4 (Integrated Intelligent Imaging Informatics) software is designed to perform digital image processing, measurement, manipulation and quantification of images, communication and storage with indications for use similar to the primary predicate device. IntelliSpace PACS 4.x (K111804).

The Indications for Use statement for I4 (Integrated Intelligent Imaging Informatics) is similar, but not identical compared to the primary predicate device, IntelliSpace PACS 4.x (K111804), and the two devices have the same intended use.

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- 트 I4 (Integrated Intelligent Imaging Informatics) software provides digital image processing function of performing image manipulation (e.g 3D rendering modes and 3d visualization) with advanced visualization and evaluation capabilities of cleared to market reference predicate devices ViewForum 2003(K032096). Brilliance iCT (Brilliance Volume)(K060937).14 system indications for use are a combination of primary predicate device and reference predicate devices, and falls within the intended use of the primary predicate device.
This difference does not alter the intended use of the device nor does it affect the safety and effectiveness of the device relative to the primary predicate IntelliSpace PACS 4.x (K111804). Both the proposed and the primary predicate device have the same intended use, a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment.

- I I4 (Integrated Intelligent Imaging Informatics) system is not to be used for mammography. This is a reduction of the IntelliSpace PACS 4.x (K111804) Indications for Use scope. This limitation is clearly indicated in the labelling and does not raise new questions on safety and/or effectiveness
Listed above differences do not alter the intended use nor do they affect the safety and effectiveness of the device relative to the primary predicate device, IntelliSpace PACS 4.x (K111804).

Based on the above, the proposed 14 (Integrated Intelligent Imaging Informatics) is considered substantially equivalent to the currently marketed and primary predicate device IntelliSpace PACS 4.x (K111804), in terms of Indications for use.

#### Comparison of Technological Characteristics with the Predicate Device VI.

I4 (Integrated Intelligent Imaging Informatics) system is an evolution of the primary predicate device IntelliSpace PACS 4.x (K111804) with additional/enhanced functionality deriving from the reference predicate devices ViewForum2003 (K032096), Brilliance Volume) (K060937), and reference device VesselNavigator (K151598).

I4 (Integrated Intelligent Imaging Informatics) is a software package used with general purpose computing hardware.

I4 (Integrated Intelligent Imaging Informatics) system uses the standard principles of operation typically seen in PACS systems such as database and image management systems, image processing tools, standard measurement tools.

Both the proposed device and the primary predicate device provide Diagnostic Review Solution for radiology, utilizing client -server technology, storage capabilities, communication and interoperability with hospital systems, such as radiology workflow providers and image archive.

A comparison matrix below (please see Table 0-1 below) provides a comparison which outlines a high level overview of the differences and similarities between 14 (Integrated Intelligent

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Imaging Informatics) system and the primary predicate device, IntelliSpace PACS 4.x (K111804) , reference predicate devices, ViewForum2003 (K032096),Brilliance iCT (Brilliance Volume) (K060937), and reference device VesselNavigator (K151598).

| # | Specification / Feature | Proposed Device:<br>I4 (Integrated<br>Intelligent<br>Imaging<br>Informatics)<br>system | Primary Predicate Device | Reference predicate Devices:<br>Brilliance iCT<br>(Brilliance Volume)<br>(K060937)<br>ViewForum2003<br>(K032096)<br>Reference device:<br>VesselNavigator<br>(K151598) |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Software Image<br>management system | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| 2. | Hardware Platform<br>requirements | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| | System Configuration | | | |
| 3. | Windows Operating<br>System | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| 4. | TCP-IP Network<br>Protocol | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| # | Specification / Feature | Proposed<br>Device:<br>I4 (Integrated<br>Intelligent<br>Imaging<br>Informatics)<br>system | Primary Predicate<br>Device<br>IntelliSpace PACS<br>4.x<br>(K111804) | Reference predicate<br>Devices:<br>Brilliance iCT<br>(Brilliance Volume)<br>(K060937)<br>ViewForum2003<br>(K032096)<br>Reference device:<br>VesselNavigator<br>(K151598) |
| 5. | Supports High<br>Resolution Diagnostic<br>Monitors | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| 6. | Storage capabilities | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| 7. | Multiple monitor<br>support | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| Communication and Interoperability with other image management systems | | | | |
| 8. | Supports DICOM studies<br>received from different<br>modalities types | Yes -<br>CT, MR, US, XA,<br>DX, CR, RF, PT<br>and SC as well as<br>hospital/radiology<br>information<br>systems | Yes-<br>CT, MR, NM, US,<br>XA, PET, DX, DR,<br>RF, RT, MG, SC,<br>VL | Yes -<br>CT, MR |
| 9. | Mammography | No | Yes | Not relevant for this<br>subject comparison as I4<br>system do not support<br>Mammography |
| # | Specification / Feature | Proposed<br>Device:<br>I4 (Integrated<br>Intelligent<br>Imaging<br>Informatics)<br>system | Primary Predicate<br>Device<br>IntelliSpace PACS<br>4.x<br>(K111804) | Reference predicate<br>Devices:<br>Brilliance iCT<br>(Brilliance Volume)<br>(K060937)<br>ViewForum2003<br>(K032096)<br>Reference device:<br>VesselNavigator<br>(K151598) |
| 10. | Accepts patient and<br>exam updates via HL7 | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| | Operating Platform requirements | | | |
| 11. | Client-server technology | Yes | Yes | No - SW designed for<br>use on workstations<br>only. |
| 12. | Thin client installer | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| 13. | Multiple concurrent user<br>support | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| | Management tools | | | |
| 14. | Auditing Tool | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| # | Specification / Feature | Proposed Device: | Primary Predicate Device: | Reference predicate Devices: |
| | | I4 (Integrated<br>Intelligent<br>Imaging<br>Informatics)<br>system | IntelliSpace PACS<br>4.x<br>(K111804) | Brilliance iCT<br>(Brilliance Volume)<br>(K060937)<br>ViewForum2003<br>(K032096)<br>Reference device:<br>VesselNavigator<br>(K151598) |
| 15. | Client installer | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| 16. | System management | Yes | Yes | Not relevant for this<br>subject comparison as<br>the proposed device<br>utilizes similar<br>technology as the<br>primary predicate |
| | Viewing and Image Processing | | | |
| 17. | Supported Data and<br>Multi Modalities | Supports<br>receiving, sending,<br>storing and<br>displaying studies<br>received from the<br>following<br>modalities via<br>DICOM:<br>CT, MR, US, XA,<br>DX, CR, RF, PT<br>and SC as well as<br>hospital /radiology<br>information<br>systems. | Supports receiving,<br>sending, printing,<br>storing and<br>displaying studies<br>received from the<br>following modality<br>types via DICOM:<br>CT, MR, NM, US,<br>XA, PT, DX, DR,<br>RF, RT, MG, SC,<br>VL, as well as<br>hospital/<br>Radiology<br>information<br>systems. | CT, MR |
| 18. | 2D basic viewing:<br>Multiple monitor layout<br>options , Scales image to<br>window, Cine | Yes | Yes | Yes |
| # | Specification / Feature | Proposed<br>Device:<br>I4 (Integrated<br>Intelligent<br>Imaging<br>Informatics)<br>system | Primary Predicate<br>Device<br>IntelliSpace PACS<br>4.x<br>(K111804) | Reference predicate<br>Devices:<br>Brilliance iCT<br>(Brilliance Volume)<br>(K060937)<br>ViewForum2003<br>(K032096)<br>Reference device:<br>VesselNavigator<br>(K151598) |
| 19. | 2D Advanced viewing:<br>Compare series<br>side-by-side, Multi-<br>Dimensional viewing | Yes | No | Yes- ViewForum2003<br>(K032096) |
| 20. | 3D volumetric viewing :<br>Volumetric image | Yes | No | Yes -Brilliance iCT<br>(Brilliance Volume)<br>(K060937) |
| 21. | Multi Planar<br>Reconstruction (MPR) | Yes | No | Yes -Brilliance iCT<br>(Brilliance Volume)<br>(K060937) |
| 22. | 3D Rendering modes<br>(MIP, MinIP, VIP<br>Surface MIP,<br>Average(AIP), Volume<br>rendering) | Yes | No | Yes -Brilliance iCT<br>(Brilliance Volume)<br>(K060937) |
| 23. | Comparison and<br>Synchronization between<br>volumetric series | Yes | No | Yes- ViewForum2003<br>(K032096) |
| 24. | Image manipulation:<br>Slab thickness and<br>orientation (for MPR<br>images), windowing,<br>zoom level, pan | Yes | No | Yes -Brilliance iCT<br>(Brilliance Volume)<br>(K060937) |
| 25. | Measurements and<br>Annotations tools<br>(for 2D and 3D viewing):<br>Straight Line, Curved<br>Line, ROI, Angle, text,<br>measurement<br>comparison | Yes-<br>Measurements<br>and Annotations<br>tools for 2D and<br>3D viewing<br>modes | Yes-<br>Measurements and<br>Annotations tools<br>for 2D viewing<br>mode | Yes- Brilliance iCT<br>(Brilliance Volume)<br>(K060937) |
| 26. | Segmentation tools:<br>Bone/Skull removal | Yes | No | Yes- Advance Vessel<br>Analysis (AVA) from<br>Brilliance iCT<br>(Brilliance Volume),<br>(K060937) |
| # | Specification / Feature | Proposed<br>Device: | Primary Predicate<br>Device | Reference predicate<br>Devices: |
| | | I4 (Integrated<br>Intelligent<br>Imaging<br>Informatics)<br>system | IntelliSpace PACS<br>4.x<br>(K111804) | Brilliance iCT<br>(Brilliance Volume)<br>(K060937)<br>ViewForum2003<br>(K032096)<br>Reference device:<br>VesselNavigator<br>(K151598) |
| 27. | Advanced vessel analysis<br>visualization and<br>evaluation mode<br>(Vascular Inspection<br>Mode) | Yes | No | Yes –<br>ViewForum<br>2003(K032096),<br>Brilliance iCT<br>(Brilliance Volume)<br>(K060937), and<br>VesselNavigator<br>(K151598).<br>I4 incorporate<br>functionalities from all<br>listed reference predicate<br>devices. |
| 28. | Incorporation of non-<br>imaging data in patient<br>context<br>(Mission Briefing) | Yes | No | No |

Table 5-1 Technological characteristics comparison

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The subject device, I4 (Integrated Intelligent Imaging Informatics) system, has implemented features designated to bring the product up to date with current technologies and customer requests. Presented technological differences are considered low risk, providing further support to clinicians in visualization. These functionalities are derived from reference predicate devices and reference device, were verified and validated and do not raise new questions on safety and/or effectiveness. These features have not changed the intended use and operational principles of the device. Therefore, the I4 (Integrated Intelligent Imaging Informatics) system is substantially equivalent to the currently marketed primary predicate device IntelliSpace PACS 4.x (K111804) in terms of technological characteristics.

#### Performance Data VII.

The following performance data were provided in support of the substantial equivalence determination.

### Summary of Non-clinical testing

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No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical performance testing has been performed on 14 (Integrated Intelligent Imaging Informatics) system and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

- 트 ISO 14971 Medical devices – Application of risk management to medical devices
- IEC 62304 Medical device software Software life cycle processes ■
- I IEC 62366-1 Medical devices – Part 1:Application of usability engineering to medical devices
- 트 NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
- . Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

I4 (Integrated Intelligent Imaging Informatics) system was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.

The test results in this 510(k) premarket notification demonstrate that 14 (Integrated Intelligent Imaging Informatics) system:

- complies with the aforementioned international and FDA-recognized consensus standards . and FDA guidance document, and
- Meets the acceptance criteria and is adequate for its intended use.

Therefore, I4 (Integrated Intelligent Imaging Informatics) system is substantially equivalent to the currently marketed primary predicate device IntelliSpace PACS 4.x (K111804) in terms of safety and effectiveness.

### Summary of Clinical Testing

The subject of this premarket submission, 14 (Integrated Intelligent Imaging Informatics) system did not require clinical studies to support equivalence.

## VIII. Substantial Equivalence Conclusion

The I4 (Integrated Intelligent Imaging Informatics) system is substantially equivalent to the currently marketed primary predicate device IntelliSpace PACS 4.x (K111804) in terms of indications for use, design features, fundamental scientific technology, and safety and/or effectiveness.

Additionally, substantial equivalence was demonstrated with non-clinical performance testing. The non-clinical performance tests provided in this 510(k) premarket notification demonstrated that the proposed I4 (Integrated Intelligent Imaging Informatics) system is as safe and effective as its primary predicate device IntelliSpace PACS 4.x (K111804) without raising any new safety and/or effectiveness concerns.